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Active, Not Recruiting

NCT Number: NCT06840470

Investigating the Effect of Topical Imiquimod on Sebaceous Hyperplasia

This study is being completed to determine if 8 weeks of treatment with imiquimod can shrink sebaceous hyperplasia.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient has sebaceous hyperplasia lesions on both sides of the face. At least one sebaceous hyperplasia lesion on each side of the face is 1 mm or more in size.
  • If of child-bearing potential, subject agrees to the use of highly effective contraception during study participation. For women of childbearing potential, acceptable pregnancy prevention measures will include abstinence, barrier methods, chemical methods, or surgical.
  • Ability to understand and willingness to sign a written informed consent

Exclusion criteria

  • Current use or prior use of a retinoid (e.g. tretinoin) within the last 4 weeks.
  • Prior use of imiquimod on the treated area.
  • Concurrent use of 5-fluorouracil, aminolevulinic acid (photodynamic therapy), or psoralen therapy, or use of any of these within the last 4 weeks.
  • Concurrent facial peels or cosmetic laser therapy on the treated areas.
  • Nursing, pregnant or planning to become pregnant.
  • Immunocompromised status (e.g. organ transplantation recipients or patients on cyclosporine).
  • Current participation in other investigational trials.
  • Known or suspected history of a clinically significant systemic disease (e.g., immunological deficiencies), unstable medical disorders (e.g., unstable diabetes), life-threatening disease or current malignancies.
  • Known hypersensitivity to any of the following (in any dosage form): imiquimod or any component of the study medications.
  • Received radiation therapy and/or anti-neoplastic agents within 3 months prior to study entry.

Treatment and study plan

Imiquimod 5% Topical Cream

Drug

Participants will apply this cream to one side of the face 3 times a week for up to 8 weeks. The cream will be applied before bedtime. The imiquimod should be washed off with mild soap and water after 6-10 hours. Participants will have baseline and follow-up visits that will include photographs of the lesions.

Other names: Aldara

Primary outcomes

  1. Complete and 75% clearance rates (clearance refers to reduction in total lesional area) at 16 weeks of treated lesions

    Time frame: 16 weeks

Secondary outcomes

  1. Mean change in Sebaceous Hyperplasia (SH) count

    Time frame: 16 weeks

  2. Mean change in Sebaceous Hyperplasia (SH) diameter

    Time frame: 16 weeks

  3. Adverse events (AE) associated with imiquimod 5% cream when used in the treatment of sebaceous hyperplasia

    Time frame: Up to 8 weeks

    The following will be described for Adverse events per protocol:

    • Serious or non-serious
    • Mild, moderate, Severe
    • The relationship (unexpected or expected) of the study drug
    • Attribution of the AE: Definite, Probably, Possible, Unlikely, Unrelated.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 21, 2025
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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